More Men Treated for Low Testosterone, Some Without Evidence

June 04, 2013

By Genevra Pittman

NEW YORK (Reuters Health) Jun 04 - The proportion of middle-aged American men being treated for low testosterone more than tripled over the last decade, a new study suggests.

Researchers analyzed health insurance claims for more than 10 million men aged 40 and over and found that by 2011, almost 3% were taking androgen replacement therapy. But not all of them had undergone a blood test to see if they really needed the extra testosterone, according to findings published June 3 in JAMA Internal Medicine.

The lead researcher said that's "concerning" because the possible long-term side effects aren't clear.

"This is not a risk-free drug, so committing to it for a long time when you're a young man - there could be some risks down the road, we don't know," said Dr. Jacques Baillargeon, from the University of Texas Medical Branch in Galveston.

Androgen replacement therapy is recommended for men with hypogonadism. But advertising campaigns may be reaching a bigger pool of men - those who are tired or depressed, for example, but don't have clinically low testosterone.

"There's all sorts of messages out there that men should be aware of this thing called low T, that low testosterone levels can be the reason for almost all of the problems with life and aging," and that treatment can fix that, said Dr. Steven Woloshin from the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire.

"The promise goes well beyond what we know, and that's what's worrisome," Dr. Woloshin, who co-wrote a commentary about testosterone marketing published in the same journal, told Reuters Health.

That marketing includes quizzes asking men about their energy, sex drive and mood, such as the "Is It Low T?" quiz (http://bit.ly/18LeuHk) sponsored by AbbVie, which makes the testosterone gel AndroGel.

For their study, Dr. Baillargeon and his colleagues used health insurance claims to track new prescriptions for androgen replacement therapy and related lab tests between 2001 and 2011.

Over that time, the proportion of middle-aged men given at least one testosterone prescription increased from 0.8%, or 1 in 125 men, to 2.9%, or about 1 in 34 men.

That rate increased in all age groups over 40, the study team found, but varied by region. For example, 3.8% of Southern men took testosterone in 2010, compared to 1.6% of men in the Northeast.

Just over one-quarter of new testosterone users did not have a blood test in the year before they were prescribed the hormone. For others, there was no information on whether their testosterone levels were low enough to warrant treatment.

About half of men were diagnosed with hypogonadism before starting treatment. Some also had fatigue or erectile dysfunction listed in their records.

An AbbVie representative told Reuters Health in an email, "Prescription topical testosterone replacement medicines can only be prescribed by a physician after taking a patient's complete medical condition into consideration. AbbVie encourages discussion between physicians and patients that leads to proper diagnosis based on symptoms, lab tests and a patient's other health needs."

For men who don't have problems producing testosterone, it's unclear whether treatment has any benefits, Dr. Baillargeon told Reuters Health. One recent study showed it did not help older men improve their overall functioning (see Reuters Health story of April 4, 2013).

Also not clear are the possible long-term side effects of androgen replacement, especially when it comes to heart disease and prostate cancer risks.

"For a younger man in particular and somebody who does not have definitely unequivocal hypogonadism, they should consider the risk-benefit ratio," Dr. Baillargeon said. "And the risks for those major outcomes... those are unknown."

"There's a lot we don't know," Dr. Woloshin agreed.

SOURCE: http://bit.ly/13CMv9M

JAMA Intern Med 2013.

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